PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

Device Description

PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed of USP sterile water and sodium chloride only and provided in 3%, 3.5%, 6%, 7%, and 10% concentrations. They are packaged sterile in standard 5ml (4ml fill) flexible material vials. The vials have a tear-off top. They are marked NOT FOR INJECTION.

AI/ML Overview

The provided document describes a 510(k) premarket notification for PharmaCaribe inhaled saline solutions. This is not a study proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it is a submission for a medical device (saline solutions) demonstrating substantial equivalence to predicate devices already on the market.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML device performance, are not applicable to this document.

Summary of Device and Approval:

Device Name: PharmaCaribe inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%
Intended Use: For the induction of sputum production where sputum production is indicated, in conjunction with a nebulizer.
Classification: Class II, Nebulizer (Direct Patient Interface), Product Code CAF
Predicate Devices: DEY Laboratories - K972778 and Pari - K070498
Approval Date: August 17, 2010
Basis of Approval: Substantial equivalence to predicate devices. The device's manufacturing and testing processes (including pH, osmolality, appearance, sterility, identification of sodium and chloride, bacterial endotoxin, iron content, heavy metals content, sodium chloride assay, and stability testing) are identical or similar to the predicate devices and conform to USP monographs.

Non-Applicability of AI/ML Study Criteria:

The questions related to acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are specifically designed for evaluating the performance of AI/ML algorithms. Since the PharmaCaribe inhaled saline solutions are a pharmaceutical-like product (albeit regulated as a medical device) and not an AI/ML system, these criteria do not apply to this 510(k) submission. The "performance testing" referenced in the document refers to chemical and sterility testing to ensure the product meets established standards, not diagnostic or predictive performance.

Summary

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510(k) Summary Page 1 of 3 14-Jul-10

K101424
AUG 17 2010

PharmaCaribe
3513 Di Leuca St.	Tel - (941) 505-0793
Punta Gorda, FL 33950	Fax - (941) 505-0718
Official Contact:	W. Randolph Warner
Proprietary or Trade Name:	PharmaCaribe inhaled saline solutions
Common/Usual Name:	Saline solution
Classification Name:	Nebulizer (Direct Patient Interface)CAF - 868.5630
Device:	Inhaled saline solutions - 3%, 3.5%, 6%, 7%, and 10%
Predicate Devices:	DEY Laboratories - K972778Pari - K070498

Device Description:

Indications for Use:

Patient Population:

Any patient population where sputum specimens are indicated

Environment of Use: Hospital, sub-acute care or home

Contraindications: None

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510(k) Summary

Features	ProposedInhaled saline solutions	PredicateDEY K972778	PredicatePari K070498
Indications for use	Used in conjunction with a nebulizer.The contents of these vials are for theinduction of sputum production wheresputum production is indicated.	Used in conjunction with anebulizer. For induction of sputumproduction where specimencollection is indicated.	Used in conjunction with anebulizer for an induction ofsputum production wherespecimen collection is indicated.
Prescription	Yes	Yes	Yes
Environment of Use	Home, Hospital, Sub-acute Institutions	Same	Same
Patient Population	For those required sputum specimens	Same	Same
Used with a nebulizer	Yes	Yes	Yes
Contraindications	None	None	None
Marked Not for Injection	Yes	Yes	Yes
Packaged sterile in aflexible tear-off top vial	Yes	Similar	Identical
Solutions	3%, 3.5%, 6%, 7% and 10%	3% and 10%	3.5%, 6% and 7%
Manufactured	Per USP monograph	Same	Same
Manufacturing processand formulation per USP	Osmolality, Appearance, Pre-filtrationBioburden, Sterility USP (71),Identification of Sodium and ChlorideUSP (191), pH USP (791),Bacterial Endotoxin USP (85), IronContent USP (241), Heavy MetalsContent USP (231), Sodium ChlorideAssay USP Monograph, 3 monthstability of solution	Similar	Identical

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510(k) Summary Page 3 of 3 14-Jul-10

Performance Testing Summary:

The PharmaCaribe inhaled saline solutions are manufactured and tested in an identical manner to the predicate Pari (K070498). This includes:

. USP Water
. Filtration - sterility grade filters
Testing for .
- o pH
- Osmolality 0
- Appearance 0
- Pre-filtration Bioburden O
- Sterility per USP (71) 0
- Identification of Sodium and Chloride per USP (191) 0
- pH per USP (791) 0
- Bacterial Endotoxin per USP (85) O
- 0 Iron Content per USP (241)
- Heavy Metals Content per USP (231) O
- Sodium Chloride Assay per USP Monograph 0
- Testing for 3 month stability of solution o

Differences between Other Legally Marketed Predicate Devices

Based upon formulation requirements as specified by the USP monograph the proposed inhale saline solutions are viewed as substantially equivalent (identical) to the predicates - DEY K972778 and Pari -- K070498.

There are no differences and thus there are no new concerns of safety or effectiveness between the intended device and the predicates.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pharmacaribe C/O Mr. Paul Dryden Promedic 24301 Woodsage Drive Bonita Springs, Florida 34134

AUG 1 7 2010

Re: K101424

Trade/Device Name: PharmaCaribe Inhaled Saline Solutions 3%, 3.5%, 6%, 7% and 10% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 14, 2010 Received: July 16, 2010

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K101424

Page 1 of 1

510(k) Number:

K101424

Device Name:

Indications for Use:

PharmaCaribe Inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Concentrations of 3%, 3.5%, 6%, 7%, and 10%

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schutter

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

-10(k) Number: ______ 10/424

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).